A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants.

Key facts

Study ID
NCT06532942
Run by
Mannkind Corporation
People needed
40
Starts
2024-05-28
Expected to finish
2024-10-31
Last updated by the study team
2024-08-06

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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